Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy

Not Applicable

Active, not recruiting

• Conditions: Stroke, Acute
• Interventions: Device: External active conductive head cooling

• Registration Number: NCT06335641
• Lead Sponsor: University of Calgary

Brief Summary

This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Study Start: 2024-07-28
• Primary Completion: 2024-11-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-30
• Study Completion: 2025-02-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.

Exclusion Criteria

• Admission core body temperature <35°C.
• Known contraindications to hypothermia, including hemodynamically unstable patients, new/symptomatic arrhythmia, hematological dyscrasias that affect thrombosis (cryoglobulinemia, sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thrombo-angiitis obliterans.
• Skin lesions not allowing secure application of the cooling cap.
• Unable to participate in follow-up at 3 months (e.g., resides outside of Alberta).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	External active conductive head cooling	Head cooling

Primary Outcome Measures

Name	Time	Method
Adherence to the intervention	From time of application in the emergency department until the end of the endovascular thrombectomy procedure	Adherence is defined as undergoing active conductive head cooling for ≥50% of the time from first application of the cooling device

Trial Locations

Locations (2)

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

Te Whatu Ora Te Toka Tumai Auckland; 🇳🇿 Auckland, New Zealand